Whitepapers

Counterfeit and substandard medicines have serious human health and economic costs the magnitude of the counterfeit and substandard drug problem has gained significant public attention due to a number of high profile incidents and greater media focus. According to the Centers for Disease Control and Prevention (CDC), an estimated 10% – 30% of medicines sold in developing countries are counterfeit.

Government health agencies and pharmaceutical manufacturers are finding ways to fight counterfeit and substandard drugs by identifying them from manufacturing, throughout the supply chain, and eventually when they reach the public after they are sold in the retail pharmacies. This whitepaper is co-authored by speaker Ravi Kalyanaraman of Bristol-Myers Squibb.

Near-Infrared (NIR) and Raman spectral techniques, which are complimentary in nature, have been used widely to detect counterfeit drugs. Both techniques are rapid, onintrusive and nondestructive that can be used for the analysis of many classes of pharmaceutical dosage forms.This whitepaper is co-authored by speaker Ravi Kalyanaraman of Bristol-Myers Squibb.

One of the effective ways to authenticate a pharmaceutical product is by using Raman spectroscopy to obtain a unique spectral ‘fingerprint’ of the authentic drug product itself that can be used to evaluate a suspect sample by spectral comparison to determine if it is indeed a counterfeit. This whitepaper is co-authored by speaker Ravi Kalyanaraman of Bristol-Myers Squibb.

Technological advancements in Micro-Electromechanical Systems (MEMS) for NIR, and in the telecommunication laser industry for Raman, along with advances in optical and detector components miniaturization for both, have led to drastic reductions in size of these spectrometers which have made them portable. This whitepaper is co-authored by speaker Ravi Kalyanaraman of Bristol-Myers Squibb.

One of the major aspects of anti-counterfeiting and brand protection for pharmaceuticals is the implementation of serialization along the supply chain. Ahead of the 7th Pharma Anti-Counterfeiting & Brand Protection summit, we examined the role that serialization challenges play on counterfeiting in pharmaceuticals, as well as sessions from the upcoming event that can help to provide more insight. To learn more about these challenges, as well as specifics regarding our corresponding sessions, make sure to download the report.

Counterfeit and diverted pharmaceuticals are major problems that put consumer health and company reputations at risk in the global market. As part of an effort to overhaul track and trace rules and increase the accuracy of supply chain information, the U.S. Food and Drug Administration (FDA) is implementing widespread changes for the pharmaceutical industry.

How can the patient be sure the medication he/she is going to take is exactly what the doctor ordered? Every year, substandard, spurious, falsely-labeled, falsified and counterfeit drugs work their way into the market and eventually into the homes and hands of patients treating everything from routine illnesses to chronic conditions.

Serialization/aggregation regulations are being implemented or are already in place, in many countries around the world.Contract development and manufacturing organizations (CDMOs) have their own unique set of challenges to meeting serialization requirements. Servier CDMO began tackling this problem early on, to not only be in compliance, but to be positioned to leverage serialization/aggregation technology and data for greater success.

Estimates suggest that the global counterfeit drug market sits somewhere between US$75 and $200 billion and represents 10–50 percent of all drugs sold in some low-income countries. This article looks at the past, present, and future of counterfeit drug screening.

This article demonstrates that Drop Coat Deposition (DCD) technique for the biologics drug product sample, coupled with confocal Raman spectroscopy can be effectively used to fingerprint protein based biologics pharmaceuticals. These spectral fingerprints can be used routinely to screen and detect biologics counterfeits.

As Internet activity grows, the availability of medication online has also increased. Consumers may be tricked into buying what they think is real only to pay the ultimate price when they take counterfeit medication. So, how can the pharmaceutical industry tackle this problem and keep consumers safe from harm?